JP2009523054A - Material recovery device and method of use - Google Patents

Abstract

  A medical device configured to be inserted into a patient's body for retrieving material from the patient's body includes a basket assembly. The basket assembly is configured to transition between various states, including an expanded state and a folded state. When in the expanded state, the basket assembly can be substantially covered by a flexible sheet except for the side openings. The side opening can be substantially closed when the basket assembly is in a folded state. While the basket assembly is in the folded state, the device can be inserted into the patient's body. The basket assembly can be transitioned to an expanded state while in the patient's body. The physician can then manipulate the material to be removed from the patient's body and place it into the basket assembly through the side opening. The basket assembly can then be transitioned to a folded or partially folded state so that the basket assembly can be removed from the patient's body.

Description

  The present invention relates to a substance recovery device and method of use.

  Urinary stones affect about 1-5% of the US population. Gallstones are found in 4-8% of people over the age of 40. There are many devices that can be used to capture and remove stones from body cavities. Similarly, many lithotripsy devices for crushing or destroying stones have been manufactured. In general, the former device consists of a basket or capture device with three or more wires used to “capture” the stone. In order to operate (mainly open and close) the wire, an operation handle remaining outside the body is used. Typically, these devices allow an operator to directly visualize the operation and / or uptake of stones through the instrument, typically through an endoscope.

  In general, it is recognized that urinary stones of 4 millimeters (mm) or less that travel to the ureter have a 85% chance of being naturally discharged from the urinary tract without surgical intervention. As the stone size increases, the likelihood of spontaneous discharge decreases significantly. Stones larger than 8 mm are rarely discharged without intervention. Using only a basket or a capture device is usually unsuccessful because the calculus is too large to withdraw. As a result, some sort of lithotripsy is usually used.

  A number of prior art devices are known. For example, US Pat. No. 5,064,428 to Cope et al. Describes a device for collecting stones. The Cope et al. Device includes a calculus recovery basket with three loops of Nitinol wire forming a sphere. The basket is coupled to an inner tube having a hollow passage. The basket and the inner tube can be inserted into the patient's body through an outer tube that also has a hollow passage. The basket can be expanded in the body by pressing the basket against tissue. The physician then rotates and manipulates the basket to capture the calculus in the basket. The inner tube is then pulled outward so that the basket is folded around the stone and the stone is pulled against the end of the outer tube. The physician can then insert chemical or other well-known surgical means to dissolve, crush or crush the stone. Debris can be removed through the hollow passage of the inner tube.

  Ciervo et al., US Pat. No. 5,403,324, describes a device for collecting stones. The Ciervo et al. Device includes a flexible catheter tube with four wires passing through four hollow passages in the catheter tube. At one end of the catheter tube, the wire escapes to form a stone recovery basket. At the other end of the catheter tube, the four wires provide a control mechanism that allows the physician to move the wire in and out of the catheter tube to expand and retract the basket. Combined. After the catheter tube is inserted into the patient's body, the physician manipulates the catheter to capture the calculus in the basket. The basket is then retracted to hold the stone against the end of the catheter tube. A laser or ultrasonic wire can then be inserted through the fifth hollow passage in the catheter tube to facilitate the lithotripsy procedure.

  Fogarty U.S. Pat. No. 3,472,230 describes an umbrella catheter having a calculus collection basket that includes four spring wires forming an umbrella frame. Usually, the wire of the umbrella frame curves outward to form a spherical umbrella frame. The umbrella frame is partially covered at the distal end of the basket with a flexible material such as a moldable elastomer. A control wire passes through the flexible catheter tube and is coupled to the proximal end of the umbrella frame. When the control wire is pulled using a handle, the four spring wires are drawn into the catheter tube and the umbrella is folded. When the control wire is pushed, the spring wire expands and the umbrella is opened. When the umbrella is closed, the physician can place the umbrella beyond the location of the calculus or debris. The doctor then opens the umbrella and pulls the device a short distance to scoop up the debris. The physician then closes the umbrella and removes the device from the body along with the calculus in the umbrella.

  Demeter, U.S. Pat. No. 4,997,435, describes a percutaneous catheter having a hermetic receptacle. The Demeter device includes a first catheter having a plurality of struts coupled to one end of the first catheter. The struts form a cup shape having an opening distal from the end of the first catheter. A pocket-shaped sheath is coupled to the strut so that a receptacle having an opening in the distal direction is formed. The proximal portion of the sheath is coupled to a second catheter that passes through the first catheter. The second catheter is slidable and rotatable within the first catheter. In the state where the strut and the sheath are not under tension, the opening of the receptacle opens. However, as the first catheter rotates with respect to the second catheter, the sheath twists relative to the strut and closes the receptacle opening at the distal end. Thus, the physician can manipulate the device with the receptacle open and capture the calculus in the receptacle. The receptacle can then be closed to seal the calculus. The second catheter includes a lumen through which grasping forceps, a speculum, or a lithotripsy device can be inserted into the sheath.

Chu et al., US Pat. No. 6,752,811, describes a plurality of different laser resistant medical retrieval devices. For example, one device includes a spherical basket formed by laser resistant basket legs. The basket can be folded by retracting the basket legs into the catheter. Chu et al. Can make the basket legs from a laser resistant material, such as fluorocarbon plastic, ceramic, or gold, silver, or nickel plating, or coat the basket legs with them. It is explained that it is possible. A laser lithotripter can pass through the device and into the basket. Chu et al., At the distal end of the basket, polytetrafluoroethylene (EPTFE), polytetrafluoroethylene (PTFE), tetrafluoroethylene (TFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA). ), Devices partially covered with laser resistant fibers such as ethylene tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF) are also described.
US Pat. No. 5,064,428 US Pat. No. 5,403,324 U.S. Pat. No. 3,472,230 US Pat. No. 4,997,435 US Pat. No. 6,752,811

  It is an object of the present invention to provide a medical device that is configured to be inserted into a patient's body to retrieve material from the patient's body.

  A medical device configured to be inserted into a patient's body for retrieving material from the patient's body includes a basket assembly. The basket assembly is configured to transition between various states, including an expanded state and a folded state. When in the expanded state, the basket assembly can be substantially covered by a flexible sheet except for the side openings. The side opening can be substantially closed when the basket assembly is in a folded state. While the basket assembly is in the folded state, the device can be inserted into the patient's body. The basket assembly can be transitioned to an expanded state while in the patient's body. The physician can then manipulate the material to be removed from the patient's body and place it into the basket assembly through the side opening. The basket assembly can then be transitioned to a folded or partially folded state so that the basket assembly can be removed from the patient's body.

  In some embodiments, the medical device can be configured to allow a lithotripsy device to be inserted into the basket assembly while a calculus is in the basket assembly. The flexible sheet that substantially covers the basket assembly generally helps to prevent or reduce the movement of calculus fragments from the basket assembly during crushed stone.

  In one embodiment, the medical device can include a handle and an elongate member having a proximal end and a distal end, the proximal end of the elongate member coupled to the handle. In addition, the medical device can include a basket assembly coupled to the distal end of the elongate member. The basket assembly can include at least three support members, each support member coupled to a proximal end coupled to the distal end of the elongate member and to a distal end of at least one other support member. A distal end. Each pair of adjacent support members may define a corresponding gap between the adjacent support member pairs. The basket assembly can further include a flexible sheet coupled to at least some of the at least three support members, the flexible sheet including all but one of the gaps. And the one gap opens when the basket assembly is in an expanded state and substantially closes when the basket assembly is in a partially folded state.

  In another aspect, a method for treatment of a substance in the body includes inserting a medical device into the body. The medical device can include a handle and an elongate member having a proximal end and a distal end, the proximal end of the elongate member coupled to the handle. The medical device can also include a basket assembly coupled to the distal end of the elongate member. The basket assembly can include at least three support members, each support member coupled to a proximal end coupled to the distal end of the elongate member and to a distal end of at least one other support member. A distal end. Each pair of adjacent support members may define a corresponding gap between the adjacent support member pairs. The basket assembly can further include a flexible sheet coupled to at least some of the at least three support members, the flexible sheet including all but one of the gaps. And the one gap opens when the basket assembly is in an expanded state and substantially closes when the basket assembly is in a partially folded state. The method includes manipulating the material into the basket assembly through the one gap when the basket assembly is in an expanded state, and partially removing the basket assembly while the material is in the basket assembly. Transitioning to a fully folded state. In addition, the method can include transitioning the basket assembly to a collapsed state while the material is in the basket assembly and removing the medical device from the body.

  In another embodiment, the medical device can include a handle and an elongate member having a proximal end and a distal end, the proximal end of the elongate member coupled to the handle. The medical device can also include a basket assembly having a proximal end and a distal end, the proximal end of the basket assembly being coupled to the distal end of the elongate member. The basket assembly can include at least three support members and a flexible sheet coupled to at least some of the support members of the at least three support members. When the basket assembly is in an expanded state, the flexible sheet can substantially cover the basket assembly except for a side opening, the side opening being proximal to the expanded basket assembly. It extends at least partially between the end and the distal end. The side opening may be substantially closed when the basket assembly is folded.

  In yet another embodiment, a method for treatment of a substance in a body includes inserting a medical device into the body. The medical device can include a handle and an elongate member having a proximal end and a distal end, the proximal end of the elongate member coupled to the handle. The medical device can also include a basket assembly having a proximal end and a distal end, the proximal end of the basket assembly being coupled to the distal end of the elongate member. The basket assembly can include at least three support members and a flexible sheet coupled to at least some of the support members of the at least three support members. When the basket assembly is in an expanded state, the flexible sheet can substantially cover the basket assembly except for a side opening, the side opening being proximal to the expanded basket assembly. It extends at least partially between the end and the distal end. The side opening may be substantially closed when the basket assembly is folded. The method includes manipulating the material into the basket assembly through the side opening when the basket assembly is in an expanded state, and folding the basket assembly while the material is in the basket assembly. Transitioning to a designated state can be further included. In addition, the method can include removing the medical device from the body.

  FIG. 1 is an explanatory diagram of an example 100 of a calculus collecting device. Device 100 includes a first elongate member 104 having a distal end 106 and a proximal end (not shown in FIG. 1). Device 100 also includes a basket assembly 108 having a proximal end 109 and a distal end 110. The distal end 106 of the first elongate member 104 is coupled to the proximal end 109 of the basket assembly 108. The proximal end of the first elongate member 104 can be coupled to a handle (not shown in FIG. 1) that will remain outside the body. Optionally, the first elongate member 104 defines a lumen (not shown in FIG. 1) so that another device, such as an inspection mirror, grasping device, lithotripsy device, etc., can be inserted into the basket assembly 108. Can be included. The first elongate member 104 can have a length such that the first elongate member 104 extends from the patient's body to the handle. Optionally, the first elongate member 104 may be much shorter. In this embodiment, the elongate member 104 can be coupled to the handle by one or more other elongate members, such as wires, plastic members, etc. that extend to the handle.

  The basket assembly 108 includes support members 112, 116, 120 and 124. For each support member, the proximal end of the support member is coupled to the distal end 106 of the first elongate member 104. In addition, for each support member, the distal end of the support member is coupled to the distal end of at least one other support member. In the exemplary device 100 of FIG. 1, the distal ends of the support members 112, 116, 120 and 124 are coupled together by a locking mechanism 128. The securing mechanism can include any of a variety of mechanisms including known mechanisms. For example, the fixing mechanism can include a connection support member using a suture material, using a urethane material, using a cap, using welding, using an adhesive, using thermal bonding, and the like.

  The support member 112 and the support member 120 can be integrated with each other. For example, the support member 112 and the support member 120 can include a single loop wire. Similarly, the support member 116 and the support member 124 can be integrated with each other. Accordingly, when the support member 112 and the support member 120 include the first wire and the support member 116 and the support member 124 include the second wire, the first wire and the second wire are coupled to each other by the fixing mechanism 128. Can be done. In addition, each end of the first wire is coupled to the distal end of the first elongate member 104, and each end of the second wire is coupled to the distal end of the first elongate member 104. sell. This configuration of support members of the basket assembly may be referred to as a tipless basket. Of course, the support member 112 need not be integrated with the support member 120, and the support member 116 need not be integrated with the support member 124. Such a configuration may be referred to as a tipped basket assembly. If all of the support members 112, 116, 120, and 124 are a single integral part, the fixing mechanism 128 can be omitted. If the basket assembly is a tipped basket assembly, the fixation mechanism 128 can include a smooth cover that helps protect the tissue.

  Each pair of adjacent support members forms a corresponding gap between the adjacent support members. For example, the support members 112 and 116 pair form a gap 132 therebetween. Similarly, the support members 116 and 120 pair form a gap 136 therebetween, and the support members 120 and 124 pair form a gap 140 therebetween. Also, the pair of support members 112 and 124 form a gap 144 therebetween.

  The flexible sheet 148 is coupled to the basket assembly 108 such that the gaps 136, 140, and 144 are substantially covered by the flexible sheet, but the gap 132 is substantially uncovered. Thus, the basket assembly 108 forms a substantially sealed basket with a basket opening in the gap 132. In the example device 100 of FIG. 1, the flexible sheet 148 is coupled to the inside of the basket assembly 108. In other embodiments, the flexible sheet 148 can be coupled to the outside of the basket assembly 108. The flexible sheet 148 can include liquid permeable sheets, such as mesh fibers, fibers with holes cut or perforated in the fibers, sheets with holes cut or perforated in the sheets, and the like. The flexible sheet 148 can also include a liquid impermeable sheet such as a nonwoven material. The flexible sheet 148 can be coupled to the basket assembly 108 using a variety of techniques, including known techniques. For example, the flexible sheet 148 can be stretched on at least a part of the support members 112, 116, 120 and 124. Further, the flexible sheet 148 can be attached to at least a part of the support members 112, 116, 120, and 124 using a fixing mechanism such as a stitching material, a urethane material, welding, an adhesive, or heat bonding. Optionally, the flexible sheet 148 can be coupled to the distal end 106 of the first elongate member 104 using any of a variety of techniques, including known techniques.

  FIG. 2 is an illustration of the basket assembly 108 of FIG. FIG. 3 is a cross-sectional view of the device 100 of FIG. In FIG. 3, the first elongate member 104 is disposed within the lumen 204 of the second elongate member 208, such as a sheath, catheter, endoscope or the like. In the embodiment shown in FIG. 3, the first elongate member 104 includes a lumen 212 through which another device, such as a speculum, a grasping device, a lithotripsy device, etc. is inserted into the basket assembly 108. Can be done.

  In order to insert the device 100 into the patient's body, the basket assembly 108 can be placed within the lumen 204 of the second elongate member 208 in a folded state. In the folded state, the basket assembly 108 can fully enter the lumen 204 of the second elongate member 208. When the distal end 216 of the second elongate member 208 is positioned in close proximity to the stone to be removed, the basket assembly 108 causes the first elongate member 104 to be distal to the second elongate member 208. Can be released from the second elongate member 208. For example, the first elongate member 104 can be slid through the second elongate member 208 in the direction of the distal end 216 while holding the second elongate member 208 in a substantially fixed position. Alternatively, the second elongate member 208 can be slid toward the proximal end of the first elongate member 104 while holding the first elongate member 104 in a substantially fixed position.

  4A, 4B and 4C are illustrations of the device 100 in different states. In FIGS. 4A, 4B and 4C, the flexible sheet 148 is not shown, and the second elongate member 208 is shown in cross-section for ease of explanation. Referring now to FIG. 4A, the basket assembly 108 is shown in an expanded state. In the expanded state, the gap 132 is open, so that the physician can manipulate the calculus into the interior of the basket assembly 108 through the opening in the flexible sheet 148 at the gap 132. In some embodiments, optionally, the physician can expand the gap 132 by pressing the distal end 110 of the basket assembly 108 against the tissue. This can help to manipulate the calculus through an opening in the flexible sheet 148 at the gap 132. Also, optionally, the physician can utilize an additional device, such as a grasping device, to help manipulate the calculus through the opening in the flexible sheet 148 at the gap 132.

  Referring now to FIG. 4B, the basket assembly 108 is shown in a partially folded state. The basket assembly 108 may, for example, cause the first elongate member 104 to slide relative to the second elongate member 208 such that the proximal end 109 of the basket assembly 108 is located within the second elongate member 208. Can be placed in this state. As can be seen in FIG. 4B, in the partially folded state, the gap 132 is substantially closed. Of course, those of ordinary skill in the art may not be able to fully close or even substantially close the gap 132 in a partially folded condition, for example due to the size, shape, and / or position of the calculus 250. You will recognize that it is possible. Also, as can be seen in FIG. 4B, the diameter of the basket assembly 108 is substantially larger than the diameter of the second elongate member 208. The diameter of the basket assembly 108 in a partially folded state can range, for example, from a calculus diameter that is not safe to remove from the patient.

  If the calculus 250 has already been manipulated into the basket assembly 108, the calculus 250 is substantially completely sealed within the flexible sheet 148 of the basket assembly 108 in a partially folded state. Thus, for example, a calculus having a diameter that is too large to allow the calculus to be safely removed can be substantially completely sealed within the flexible sheet 148 in a partially folded state. As described in more detail below, a lithotripsy device can be used to break up such stones. Of course, smaller stones can also be substantially completely sealed within the flexible sheet 148 in a partially folded state. Optionally, the basket assembly 108 can transition back to the expanded state so that the captured calculus is “dropped” through the gap 132 as needed.

  In some embodiments, the first elongate member 104 has a lumen through which a lithotripsy device is inserted into the basket assembly while the basket assembly 108 is in a partially folded state. sell. In these embodiments, while the calculus 250 is completely sealed within the flexible sheet 148, the physician can crush the large calculus 250 using a lithotripsy device. In this way, calculus fragments can remain inside the basket assembly 108.

  Referring now to FIG. 4C, the basket assembly 108 is shown in a folded state compared to the partially folded state shown in FIG. 4B. The basket assembly 108 may, for example, cause the first elongate member 104 to slide relative to the second elongate member 208 such that a substantial portion of the basket assembly 108 is located within the second elongate member 208. Can be put in this state. The physician can place the basket assembly 108 in this state after crushing the calculus 250 using, for example, a lithotripsy device. FIG. 4C also shows that the calculus 250 has been broken into pieces 252, 254 and 256, and these pieces remain inside the basket assembly 108.

  As can be seen from FIG. 4C, in the folded state, the gap 132 is substantially closed. Of course, those skilled in the art may have examples in which the gap 132 is not fully closed or even substantially closed in the folded state due to, for example, the size, shape, arrangement, and / or position of the calculus fragments. You will recognize that it is possible. Also, as can be seen from FIG. 4C, the diameter of the basket assembly 108 is substantially smaller than the diameter in the partially folded state. The folded basket assembly 108 diameter may allow the basket assembly 108 to be safely removed from the patient's body. In some cases, the physician can fully retract the basket assembly 108 into the second elongate member 208.

  As described above with reference to FIG. 1, the proximal end of the first elongate member 104 is coupled to the handle. As described above with respect to FIGS. 4A, 4B and 4C, the handle must incorporate a device so that the physician can move the first elongate member 104 axially relative to the second elongate member 208. is there. Examples of such devices include levers, slides, triggers and the like. Those skilled in the art will recognize many other suitable devices. In addition, devices that will be developed in the future may be used.

  In general, the exemplary device 100 described above includes a basket assembly that is substantially sealed by a flexible sheet except for side openings. It is believed that the side openings can be more helpful to a physician manipulating the stone into the basket assembly, at least in some situations, as compared to baskets with anterior or distal end openings. Usually, during a stone retrieval procedure, the basket is delivered through an endoscope, often making it difficult to see the distal end of the basket. Thus, if the basket opening is on the side as compared to a basket with an anterior or distal end opening, the physician may be able to better observe the calculus and basket opening, at least in some circumstances.

  In addition, the basket opening of the exemplary device 100 described above can be generally closed while the basket assembly is in a partially folded state. Because the basket assembly 108 of the exemplary device 100 is substantially covered with a flexible sheet 148 and the basket opening can be closed, the calculus is flexible when the basket assembly is in a partially folded state. The sheet 148 can be substantially sealed. This can help prevent the stone from escaping once it has been manipulated and placed in the basket assembly 108. When lithotripsy is used, when the calculus is crushed, a substantial seal within the flexible sheet 148 can help prevent the calculus fragments from escaping from the basket assembly 108. This can help alleviate the need for repeated passes to remove only one or two calculus fragments at a time, as required by typical prior art devices. In addition, this can help to prevent leaving stone fragments behind. Such stone fragments left behind can cause stone blockage or remodeling.

  When lithotripsy is used, generally the basket assembly 108 of the exemplary device 100 can be further folded after the stone has been crushed. Generally, the basket assembly 108 is elongated in the folded state and its diameter decreases. This allows safe removal of the device from the patient's body.

  In FIGS. 1, 2, 3, 4A, 4B, and 4C, an example device 100 is shown but is substantially covered with a flexible sheet and substantially closed in a partially folded state. Other devices having basket assemblies with possible side openings may be used. For example, FIG. 5 is an illustration of an exemplary basket assembly 300 viewed from its distal end. The example basket assembly 300 includes a plurality of support members 304, 308, and 312. For each support member, the proximal end of the support member is coupled to the distal end of a first elongate member (not shown). In addition, for each support member, the distal end of the support member is coupled to the distal end of at least one other support member. In the exemplary basket assembly 300, the distal ends of the support members 304, 308, and 312 are coupled together by a locking mechanism 314. The locking mechanism 314 can include any of a variety of mechanisms including known mechanisms. For example, the securing mechanism can include suture material, urethane material, cap, welding, adhesive, thermal bonding, and the like. The two or more support members 304, 308, and 312 may be a single unitary piece. If all of the support members 304, 308 and 312 are a single unitary piece, the fixing mechanism 314 can be omitted. The basket assembly 300 may be a tipped or tipless basket.

  Each pair of adjacent support members forms a corresponding gap between adjacent support members. For example, the pair of support members 304 and 308 forms a gap 320 therebetween.

  A flexible sheet 316 is coupled to the basket assembly 300 such that the gap 320 is substantially uncovered. Accordingly, the basket assembly 300 forms a substantially sealed basket having a basket opening in the gap 320. The flexible sheet 316 can be coupled to the interior or exterior of the basket assembly 300.

  FIG. 6 is an illustration of an exemplary basket assembly 350 as viewed from its distal end. The example basket assembly 350 includes a plurality of support members 354, 358, 362, 366, 370 and 374. For each support member 354, 358, 362, 366 and 370, the proximal end of the support member is coupled to the distal end of a first elongate member (not shown). In addition, for each support member, the distal end of the support member is coupled to the distal end of at least one other support member. In the exemplary basket assembly 350, the distal ends of the support members 354 and 358 are coupled to each other by a locking mechanism 378 and to the first end of the support member 374. The distal ends of the support members 362, 366, and 370 are coupled to each other by a locking mechanism 382 and to the second end of the support member 374. The two or more support members 354, 358, 362, 366, 370 and 374 may be one or more single integral pieces. If all of the support members 354, 358, 362, 366, 370 and 374 are a single integral part, the fixing mechanisms 378 and 382 can be omitted. The basket assembly 350 may be a tipped or tipless basket.

  Adjacent pairs of support members 354 and 358 form a gap 390 therebetween. Flexible sheet 386 is coupled to basket assembly 350 such that gap 390 is substantially uncovered. Thus, the basket assembly 350 forms a substantially sealed basket having a basket opening in the gap 390. The flexible sheet 386 can be coupled to the interior or exterior of the basket assembly 350.

  In the exemplary basket assemblies 108, 300, and 350, the support member between which the basket opening is positioned is shorter in length than one of the other support members. This is one optional aspect of the basket assembly that serves to configure the basket assembly such that the basket opening substantially closes in a partially folded state. However, other approaches can be used to help construct the basket assembly such that the basket opening is substantially closed in a partially folded state.

  FIG. 7 is an explanatory diagram of an example 400 of a calculus collection device. Device 400 includes a basket assembly 404 having a proximal end 406 and a distal end 408. The proximal end 406 of the basket assembly 404 is coupled to the distal end of the first elongate member. In FIG. 7, the first elongate member is in the second elongate member. The distal end of the first elongate member can be coupled to a handle (not shown in FIG. 7) that remains outside the body. The first elongate member can include a lumen (not shown in FIG. 1) such that another device, such as an inspection mirror, grasping device, lithotripsy device, etc., can be inserted into the basket assembly 404.

  The basket assembly 404 includes support members 416, 420, 424 and 428. For each support member, the proximal end of the support member is coupled to the distal end of the first elongate member. In addition, for each support member, the distal end of the support member is coupled to the distal end of at least one other support member. In the exemplary device 400 of FIG. 7, the distal ends of the support members 416, 420, 424, and 428 are coupled together by a locking mechanism 432. If the basket assembly 404 is a tipped basket assembly, the fixation mechanism 432 can include a smooth cover that helps protect the tissue. The basket assembly 404 also includes a flexible sheet 436 that substantially seals the basket assembly except for a hole 440 between adjacent support members 416 and 420. The flexible sheet 436 can be coupled to the interior or exterior of the basket assembly 404.

  In FIG. 7, the basket assembly 404 is shown in an expanded state. FIG. 8A is a cross-sectional view of the basket assembly 404 and the second elongate member 412, showing the basket assembly 404 in a folded state within the second elongate member 412. FIG. 8A also shows a cross-sectional view of the first elongated member 450. The first elongate member 450 includes a lumen 454 through which another device, such as a speculum, a gripping device, a lithotripsy device, etc. can be inserted into the basket assembly 404. FIG. 8B shows the basket assembly 404 in a folded state and partially disposed from the second elongate member 412.

  In FIG. 9A, calculus 468 is captured in basket assembly 404. In addition, a lithotripsy device 476 has been inserted into the basket assembly 404 through the lumen 454. FIG. 9B shows the calculus 468 after it has been crushed. The flexible sheet 436 helps to maintain the stone fragment 480 in the basket assembly 404. In addition, because the calculus 468 is crushed, the basket assembly 404 can be moved to a folded state for removal from the patient's body.

  With respect to the embodiments described above, generally, the support member of the basket assembly should include a material that exhibits properties that allow the basket assembly to change between a folded state and an expanded state. In addition, the material must be biocompatible and, in devices used to remove kidney stones or gallstones, include materials that are compatible with urogenital fluid or bile, respectively. Depending on the intended use of the device, the support member can be of various materials such as acids, bases, salts, gases, solvents, and / or various forms such as mechanical energy, acoustic energy, laser energy, etc. Must be able to withstand exposure to energy. Thus, different uses of the device can impose different requirements on the support member. Conditions that can be considered when selecting materials for the support member include the intended service life of the device, whether the device is used with a lithotripsy device, the type of lithotripsy device with which the device is to be used, etc. , Is included. A binary nickel titanium US Navy Weapons Institute (NITINOL) material is one suitable material. Those skilled in the art will recognize other suitable materials such as metal, steel, and the like. Furthermore, new suitable materials can be developed in the future.

  With respect to the flexible sheet, it needs to include a material that exhibits properties that allow the basket assembly to change between a folded state and an expanded state. In addition, the material must be biocompatible and, in devices used to remove kidney stones or gallstones, include materials that are compatible with urogenital fluid or bile, respectively. In general, flexible sheets need to be able to withstand exposure to various materials, depending on the intended use of the device. For example, depending on the intended use, the flexible sheet may be in various forms such as materials such as acids, bases, salts, gases, solvents, and / or mechanical energy, acoustic energy, laser energy, etc. Can be exposed to energy. Accordingly, different uses of the device may impose different requirements on the flexible sheet. Conditions that may be considered when selecting a material for a flexible sheet include the intended service life of the device, whether the device is used with a lithotripsy device, or the lithotripsy device with which the device is to be used. Type etc. are included. In general, a variety of materials can be used including ceramics, polymers, metallic carbon fibers / composites, and the like.

  FIG. 10 is a flow diagram of an example method 500 for removing material from a patient's body using a device such as the example device described above. For ease of explanation, the method 500 is described with reference to the example device 100. However, those skilled in the art will appreciate that the method may be practiced using other devices, such as the other devices described above. At block 404, the device 100 may be inserted into the patient's body while the basket assembly 108 is in a folded state. For example, the basket assembly is sealed and folded inside a casing, sheath, catheter, endoscope, ureteroscope, etc. (hereinafter “delivery device”), and the delivery device is inserted into the patient's body. Can be done. Device 100 may be inserted into the delivery device before and after the delivery device is inserted into the patient's body.

  At block 508, the basket assembly 108 is placed in proximity to the material to be removed. This can include, for example, placing the end of the delivery device proximate to the substance while the basket assembly 108 is proximate to the end of the delivery device. As another example, first, the end of the delivery device may be placed proximate to the substance, and then the basket assembly 108 may be moved proximate to the end of the delivery device.

  At block 512, the physician can transition the basket assembly 108 to the expanded state. For example, the physician can remove the basket assembly 108 from the end of the delivery device. This may include, for example, sliding the first elongate member 104 relative to the second elongate member 208 and within the lumen 204 of the second elongate member 208 toward the distal end 216 of the second elongate member 208. A moving step can be included. The physician can use a handle, lever, slide, trigger, etc. to eject the basket assembly 108 from the end of the delivery device. As described above, the side openings of the basket assembly 108 can serve to manipulate the material into the basket assembly 108 as compared to the forward or distal end open basket.

  At block 516, the physician can manipulate the material into the basket assembly 108 through the side opening in the gap 132. For example, the physician can manipulate the basket assembly 108 into the patient's body using the handle of the device 100. Optionally, the physician can utilize another device, such as a grasping device, to manipulate the material into the basket assembly 108. Manipulating the material into the basket assembly 108 may optionally include pressing the distal end 110 of the basket assembly 108 against the tissue to expand the gap 132.

  After the material enters the basket assembly, the physician can transition the basket assembly 108 to a partially folded state. This can include, for example, partially retracting the basket assembly 108 into the delivery device. Such retraction, for example, causes the first elongate member 104 to move from the distal end 216 of the second elongate member 208 relative to the second elongate member 208 and within the lumen 204 of the second elongate member 208. A step of sliding in the direction of separation may be included. A physician can partially retract basket assembly 108 into the delivery device using a handle, lever, slide, trigger, or the like. As described above, in the partially folded state, the gap 132 in the basket assembly 108 is substantially closed.

  Blocks 524, 528 and 532 are implemented when the device 100 includes a lumen 212 in the first elongate member 104. If device 100 does not include the lumen, blocks 524, 528, and 532 may optionally be omitted. At block 524, it may be determined whether lithotripsy is required. For example, it can be determined whether the calculus has a diameter that is too large to allow it to be safely removed from the patient's body using the device 100. If it is determined that lithotripsy is required, the flow can proceed to block 528.

  At block 528, the lithotripsy device can be inserted into the basket assembly 108 through the lumen 212. The lithotripsy device used can be any of a variety of lithotripsy devices, such as mechanical devices, devices that deliver chemicals to stones, acoustic devices, laser devices, electro-hydraulic lithotripsy devices, and the like. Next, at block 532, the calculus can be crushed using a lithotripsy device. Because the basket assembly 108 is substantially sealed by the flexible sheet 148, calculus fragments should typically remain in the basket assembly 108.

  If lithotripsy is not required, or if the stone is crushed, the physician can move the basket assembly 108 to a collapsed state at block 536. This can include, for example, more fully retracting the basket assembly 108 into the delivery device. Such retraction, for example, causes the first elongate member 104 to move from the distal end 216 of the second elongate member 208 relative to the second elongate member 208 and within the lumen 204 of the second elongate member 208. A step of sliding in the direction of separation may be included. The physician can use the handle, lever, slide, trigger, etc. to more fully retract the basket assembly 108 into the delivery device.

  Next, at block 540, the physician can remove the device. This can include sliding the device 100 through the delivery device and out of the delivery device while the delivery device remains in the patient's body. This can also include removing the delivery device from the patient's body while the device 100 is positioned within the delivery device.

  Referring again to FIG. 1, in embodiments where a laser lithotripsy device is used with device 100, flexible sheet 148 and / or support members 112, 116, 120, and 124 are made of a material that is resistant to laser damage. Can be included. In addition, the flexible sheet 148 and / or the support members 112, 116, 120, and 124 can be configured to increase resistance to laser damage. A direct hit with a lithotripsy laser can break or break the wire of a typical calculus recovery basket. As is well known to those skilled in the art, crushing or breaking a stone recovery basket while in the patient's body is a highly detrimental event.

  The cross-sectional shape of the support member can affect the resistance to damage by the laser. Bishoff, “The Broken Stone Basket: Configuration and Technique for Removal,” J. Endourology, 15 (9), pp. 911-13 (2001) (hereinafter “Bishoff”), “A basket with round wire and small diameter. Tends to have less energy to break than flat wire baskets. " Therefore, flat wires tend to have higher laser resistance than round wires. Moreover, when the cross-sectional area of the wire is increased, the laser resistance tends to be increased.

  Table 1 lists the energy levels shown by Bisoff required to break the wire in various commercial stone recovery baskets. Each basket listed in Table 1 is formed from a wire made of NITINOL material.

Typically, two types of lasers are used in urinary tract applications: holmium: yttrium-aluminum-garnet (Ho: YAG) laser and neodymium: yttrium-aluminum-garnet (Nd: YAG) laser. Ho: YAG laser emits energy pulsation like, when used in _{H 2} O-based medium, usually, the absorption depth of tissue 1-2 mm (mm). The optical energy of the Ho: YAG laser provides good hemostasis when used in a pulse mode between 10 Hz and 1.6 Joules / pulse for 250 milliseconds (ms). The Ho: YAG laser superheats H ₂ O that absorbs light energy. The Ho: YAG laser is mid-infrared that is well absorbed by H ₂ O. On the other hand, the Nd: YAG laser is near-infrared and is irradiated in a continuous pulsating manner. The wavelength of the Ho: YAG laser (λ) is 2.1 micrometers (μm) and has a typical energy output of 1-5 joules. The wavelength of the Nd: YAG laser is 1.064 μm.

  Since the 1980s, NITINOL materials have been increasingly used in various medical devices. Direct radiation of the Ho: YAG laser onto the NITINOL wire can break the wire. The binary system NITINOL is mainly used for medical devices. Binary NITINOL has optimal superelastic behavior at body temperature of about 38 ° C.

  One approach to improve the laser resistance of a wire such as a NITINOL wire is to at least partially coat a laser resistant coating. Such coatings can include one or more ceramic materials, fluorocarbon plastics, plating of gold, silver, nickel, etc. polished to a reflective surface, and the like. Regarding cost, ceramic or polymer type composites may be more cost effective than other coatings if the stone recovery device is discarded after one treatment. However, the coating technique can have drawbacks. For example, it may be difficult to fully adhere the coating to the wire. Also, deformation of the basket during use can cause cracking of the coating. Further, the coating of material can cause cracking of the wire or change the flexibility of the wire. In addition, coatings that require heat above 300 ° C. may not be used for NITINOL wire because heating can change the flexibility and properties of the wire.

  Referring again to FIG. 1, if the flexible sheet 148 is laser resistant, the flexible sheet 148 is coupled inside the basket assembly 108, and a laser lithotripsy device is used inside the basket assembly 108, The flexible sheet 148 can help protect the support members 112, 116, 120 and 124 from laser damage (of course, in other embodiments, a laser lithotripsy device is used inside the basket assembly 108. In some cases, the flexible sheet 148 may be coupled to the exterior of the basket assembly 108). The laser resistant flexible sheet 148 can be made of various materials such as polymers, carbon fibers, ceramics, gold, silver, polished nickel, copper, carbon fibers / composites, and the like.

  Fluorocarbon polymers such as expanded polytetrafluoroethylene (ePTFE) are resistant to Ho: YAG lasers. Medical grade expanded ePTFE is microporous and therefore has minimal environmental humidity absorption. EPTFE is biocompatible, soft and flexible, has a high linear strength, and a low dielectric constant. An example of ePTFE fiber is W.W. L. MYCROMESH (registered trademark) mesh material manufactured by Gore & Associates. This mesh material is made of ePTFE and has a microporous structure. MYCROMESH® material is used for hernia repair and is generally considered not laser resistant. InterNet, Inc. Has developed a polytetrafluoroethylene (PTFE) mesh, InterNet, Inc. In my opinion, it is neither microporous nor laser resistant. InterNet also states that it is suitable for high temperature applications and is generally chemically resistant. In general, ePTFE and / or PTFE mesh can be microporous or non-microporous depending on the intended application. Similarly, ePTFE and / or PTFE mesh can be laser resistant or non-laser resistant depending on the intended application.

Currently, silver plated polymer (nylon) mesh fibers are available. Two examples of these fibers, high performance silver mesh fibers and see-through conductive fibers, are described at http://www.lessemf.com/fabric.html. High performance silver mesh fibers include elastic silver plated nylon weave. This unique mesh material shields low-intensity high frequencies and microwaves and can be an excellent electric field shield when grounded. This silver mesh fiber material weighs 40 g / m ² , has a temperature in the range of −30 ° C. to 90 ° C., and has an electrical resistance of less than 0.5 Ω / m. The see-through conductive fiber is a stretchable sheer nylon weave. This unique material shields low intensity high frequencies and microwaves. This is an excellent electric field shield when grounded. The fiber is a diamond-shaped knit pattern and has a weight of 0.3 oz / yd ² .

  A company called Precision Forming has developed a variety of lightweight flexible materials by electroforming mesh fibers. Electroforming involves depositing an electroplatable metal on a conductive patterning surface using an electrolytic cell. Precision Forming produces a series of electroformed mesh materials from copper, gold and nickel.

  In general, if flexible sheet 148 is laser resistant, it can be ePTFE, PTFE, tetrafluoroethylene (TFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA), ethylene tetrafluoroethylene (ETFE). ), Materials such as polyvinylidene fluoride (PVDF), and the like. In addition, the flexible sheet 148 can include a ceramic material, gold polished to a reflective surface, silver, nickel plating, or the like.

  With regard to the structure of the basket assembly 108, Bischoff has found that a basket assembly having a tip tends to be less susceptible to damage by a laser than a basket assembly having no tip. It is believed that a tipped basket tends to have an outwardly protruding broken segment when broken. In baskets without tips, the broken segments tend to have less change in their shape than baskets with broken tips.

  In one specific embodiment in which device 100 is used with a laser lithotripsy device, support members 112 and 120 include a first NITINOL wire and support members 116 and 124 include a second NITINOL wire. In this particular embodiment, the flexible sheet 148 includes ePTFE fibers. One skilled in the art will appreciate that other materials may be used in other embodiments. In addition, instead of support members 112, 116, 120, and 124 including two separate wires, for example, support members 112, 116, 120, and 124 can include four separate wires.

  Table 2 lists the results of the test with PTFE mesh bonded to the inside of the NITINOL wire basket without tip and PTFE mesh bonded to the outside of the NITINOL wire basket without tip. Each of these baskets was then emitted internally by a Ho: YAG laser. As can be seen from Table 2, placing the PTFE mesh in the basket appeared to help protect the NITINOL wire from damage.

  Table 3 lists the results of the tests in which the PTFE mesh was placed on a thin NITINOL wire and placed on a thick NITINOL wire basket.

  Table 4 lists the results of the tests emitted by the Ho: YAG laser while the mesh material was in various environments.

  In the test sample, PTFE mesh and 240-480 micron ePTFE sheet appeared to withstand the Ho: YAG laser better than other materials under various conditions. In general, thin meshes are highly flexible but can have low strength. Currently, it is believed by the inventors that a PTFE mesh or ePTFE mesh having a thickness generally in the range of about 100-300 microns will provide adequate laser resistance, strength, and flexibility. However, other thicknesses may be appropriate, such as thickness less than 100 microns or greater than 300 microns. In addition, the appropriate thickness may vary depending on the material used. Furthermore, it should be understood that the fiber need not include PTFE or ePTFE.

  While the invention is susceptible to various modifications and alternative constructions, certain exemplary embodiments thereof are shown in the drawings and are herein described in detail. However, there is no intention to limit the present disclosure to a specific disclosure form, and conversely, all modifications, alternative configurations, and equivalent forms included within the spirit and scope of the present disclosure as defined by the appended claims. It needs to be understood that it is intended.

It is explanatory drawing which shows an example of a calculus collection | recovery device. 2 is an illustration showing the basket assembly of FIG. 1 as viewed from the distal end. FIG. It is sectional drawing which shows the device of FIG. FIG. 2 is an explanatory view showing the basket assembly of FIG. 1 in an expanded state. 2 is an illustration showing the basket assembly of FIG. 1 in a partially folded state. FIG. FIG. 2 is an explanatory view showing the basket assembly of FIG. 1 in a folded state. It is explanatory drawing which shows another example of the basket assembly seen from the distal end. It is explanatory drawing which shows another example of the basket assembly seen from the distal end. It is explanatory drawing which shows another example of a calculus collection | recovery device. FIG. 8 is a cross-sectional view of the basket assembly of the device of FIG. 7 in a folded state and disposed within the delivery device. FIG. 8 is a cross-sectional view of the basket assembly of the device of FIG. 7 in a folded state and partially deployed from the delivery device. FIG. 8 is a cross-sectional view showing the basket assembly of the device of FIG. 7 in an expanded state and having a calculus in the basket assembly. FIG. 8 is a cross-sectional view of the basket assembly of the device of FIG. 7 in a folded state and having a calculus fragment within the basket assembly. 2 is a flowchart illustrating an example of a method using a device for removing a substance from a body.

Claims (30)

A handle,
A first elongate member having a proximal end and a distal end, the proximal end coupled to the handle;
A basket assembly coupled to a distal end of the first elongate member;
With
The basket assembly includes at least three support members, each support member being coupled to a proximal end coupled to a distal end of the elongate member and to a distal end of at least one other support member. Each pair of adjacent support members defines a corresponding gap between the adjacent support member pairs, and the basket assembly includes at least a portion of the at least three support members. A flexible sheet coupled to a support member, the flexible sheet substantially covering all but one of the gaps, the one gap being in an expanded state of the basket assembly; Open when the basket assembly is in a partially folded state, and substantially closed when the basket assembly is in a partially folded state,
A medical device characterized by that.   A second elongate member having a lumen, wherein the first elongate member is at least partially disposed within the lumen, the first elongate member relative to the second elongate member; The medical device of claim 1, wherein the medical device is capable of moving axially within the lumen.   The medical device according to claim 1 or 2, wherein the first elongate member includes a lumen that allows insertion of a device into the basket assembly through a distal end of the first elongate member. device.   The medical device according to claim 1, wherein the at least three support members include four support members.   The medical device of claim 4, wherein the four support members include four separate support members coupled together by a securing mechanism.   6. The medical device of claim 5, wherein the four separate support members include four separate nitinol wires.   The first pair of four support members includes a first integral member, the second pair of four support members includes a second integral member, and the first pair is secured by a securing mechanism. The medical device of claim 4, wherein the medical device is coupled to the second pair.   The medical device according to claim 7, wherein the first integral member includes a first nitinol wire and the second integral member includes a second nitinol wire.   The medical device according to claim 4, wherein the four support members include a single integral member.   The medical device according to any one of claims 1 to 9, wherein two support members adjacent to the one gap have a shorter length than at least one other support member.   The distal end of at least two of the support members is coupled to each other at a point offset from an axis extending distally from the distal end of the first elongate member. The medical device according to one item.   The medical device according to claim 1, wherein the flexible sheet comprises a non-woven material.   The medical device according to any one of claims 1 to 11, wherein the flexible sheet includes mesh fibers.   The medical device according to any one of the preceding claims, wherein the flexible sheet is internal to the basket assembly.   The medical device according to any one of the preceding claims, wherein the flexible sheet is external to the basket assembly.   The medical device according to any one of the preceding claims, wherein the first elongate member extends sufficiently to the handle.   16. The medical device of any one of claims 1-15, wherein the first elongate member is coupled to the handle via at least a third elongate member that extends sufficiently to the handle. .   The medical device according to any one of claims 1 to 17, wherein the flexible sheet comprises a laser resistant material.   The medical device according to any one of claims 1 to 18, wherein the flexible sheet comprises a mesh comprising ePTFE.   The medical device according to claim 1, wherein the flexible sheet includes a mesh including PTFE.   21. Any of the preceding claims, wherein the flexible sheet comprises fibers comprising at least one of ePTFE, PTFE, TFE, FEP, PFA, ETFE, PVDF, ceramic material, gold, silver, or nickel. A medical device according to claim 1. A method for the treatment of substances in the body,
Including inserting a medical device into the body;
The medical device is
A handle,
A first elongate member having a proximal end and a distal end, the proximal end coupled to the handle;
A basket assembly coupled to a distal end of the first elongate member;
With
The basket assembly includes at least three support members, each support member being coupled to a proximal end coupled to a distal end of the elongate member and to a distal end of at least one other support member. Each pair of adjacent support members defines a corresponding gap between the adjacent support member pairs, and the basket assembly includes at least a portion of the at least three support members. A flexible sheet coupled to a support member, the flexible sheet substantially covering all but one of the gaps, the one gap being in an expanded state of the basket assembly; Open when the basket assembly is in a partially folded state, and substantially closed when the basket assembly is in a partially folded state,
Furthermore,
Manipulating the material into the basket assembly through the one gap when the basket assembly is in an expanded state; and
Transitioning the basket assembly to a partially folded state while the material is in the basket assembly;
Transitioning the basket assembly to a folded state while the material is in the basket assembly;
Removing the medical device from the body;
A method characterized by comprising. The first elongate member includes a lumen that allows insertion of a second medical device through the distal end of the elongate member and into the basket assembly;
Furthermore,
Inserting the second medical device through the second lumen and into the basket assembly;
Treating the substance with the second medical device while the substance is in the basket assembly and while the basket assembly is in a partially folded state;
23. The method of claim 22, comprising: Manipulating the substance into the basket assembly includes manipulating a calculus into the basket assembly, wherein the calculus is substantially larger than the diameter of the delivery device for the medical device. Have
Processing the material with the second medical device while the material is in the basket assembly is such that the basket assembly is folded while at least one smaller stone is in the basket assembly. 24. A method according to claim 22 or 23 comprising the step of transforming the calculus into the at least one smaller calculus so that it can be transferred.   Treating the substance with the second medical device while the substance is in the basket assembly comprises a mechanical device, a device that delivers a chemical to the stone, an acoustic device, a laser device, or an electrohydrolithic stone 25. A method according to any one of claims 22 to 24, comprising utilizing at least one of the devices. The flexible sheet comprises a laser resistant material;
The elongate member includes a lumen that allows insertion of a laser lithotripsy device into the basket assembly through a distal end of the elongate member;
Furthermore,
Inserting the laser lithotripsy device through the lumen of the elongate member into the basket assembly;
Crushing the calculus using the laser lithotripsy device while the calculus is in the basket assembly and while the basket assembly is in a partially folded state;
Including
26. Transitioning the basket assembly to a folded state comprises transitioning the basket assembly to a folded state while at least some calculus fragments are in the basket assembly. The method as described in any one of. A handle,
An elongate member having a proximal end and a distal end, the proximal end coupled to the handle;
A basket assembly having a proximal end and a distal end;
With
A proximal end of the basket assembly is coupled to a distal end of the elongate member, and the basket assembly is coupled to at least three support members and at least a portion of the at least three support members. A flexible sheet, wherein the flexible sheet substantially covers the basket assembly except for a side opening when the basket assembly is in an expanded state, and the side opening is in an expanded state. Extending at least partially between a proximal end and a distal end of the basket assembly so that the side opening is substantially closed when the basket assembly is in a folded state. ,
A medical device characterized by that. The flexible sheet comprises a laser resistant material;
28. The medical device of claim 27, wherein the elongate member includes a lumen that allows insertion of a laser lithotripsy device into the basket assembly through a distal end of the elongate member. A method for the treatment of substances in the body,
Including inserting a medical device into the body;
The medical device is
A handle,
An elongate member having a proximal end and a distal end, the proximal end coupled to the handle;
A basket assembly having a proximal end and a distal end;
With
A proximal end of the basket assembly is coupled to a distal end of the elongate member, and the basket assembly is coupled to at least three support members and at least a portion of the at least three support members. A flexible sheet, wherein the flexible sheet substantially covers the basket assembly except for a side opening when the basket assembly is in an expanded state, and the side opening is in an expanded state. Extending at least partially between a proximal end and a distal end of the basket assembly so that the side opening is substantially closed when the basket assembly is in a folded state. ,
Furthermore,
Manipulating the material into the basket assembly through the side opening when the basket assembly is in an expanded state; and
Transitioning the basket assembly to a folded state while the material is in the basket assembly;
Removing the medical device from the body;
A method comprising the steps of: The flexible sheet comprises a laser resistant material;
The elongate member includes a lumen that allows insertion of a laser lithotripsy device into the basket assembly through a distal end of the elongate member;
Furthermore,
Inserting the laser lithotripsy device through the lumen of the elongate member into the basket assembly;
Crushing the calculus with the laser lithotripsy device while the calculus is in the basket assembly and while the basket assembly is in a partially folded state;
Including
30. Transitioning the basket assembly to a folded state comprises transitioning the basket assembly to a folded state while at least some calculus debris is in the basket assembly. the method of.

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